Kangaroo mother care combined with sucrose to reduce pain responses in preterm infants

The efficacy of kangaroo mother care combined with oral sucrose to reduce pain responses in preterm infants: a randomised multicentre clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN73259137

Enrollment

120

Registered

2010-07-20

Start date

2007-03-25

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural pain during venipuncture Signs and Symptoms Procedural pain

Interventions

1. Oral sucrose with pacifier, 2 minutes before venipuncture 2. Kangaroo mother care during 30 minutes before and during venipuncture plus oral sucrose with pacifier 2 minutes before venipuncture Infa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gestational age between 28 and 36 weeks 2. Postnatal age less than 28 days

Exclusion criteria

Exclusion criteria: 1. Apgar score less than 6 at 5 minutes 2. Surgery 3. Major congenital anomalies 4. Genetic anomaly 5. Intra-ventricular haemorrhage (IVH) greater than Grade 2 or subsequent periventricular leucomalacia 6. Severe illness as defined by hypo or hyperthermia, need for respiratory support (ventilation or nasal continuous positive airway pressure [CPAP]), inotropic therapy 7. Presence of umbilical catheter 8. Painful procedure in the previous 12 hours 9. Opioid or non-opioid sedation on the 48 hours prior to data collection 10. Diabetic mother 11. Mother with history of substance abuse 12. Mother absent or unable to do kangaroo care for clinical reasons 13. Mother cannot speak/read Portuguese

Design outcomes

Primary

Measure	Time frame
Pain responses measured by: 1. Premature Infant Pain Profile Scores 2. Changes in heart rate 3. Changes in oxygen saturation 4. Changes in behavioural state 5. Percentage of time displaying facial actions 6. Heart rate variability 7. Recovery time Primary outcome measures were taken at baseline (30 seconds before venipuncture); during skin cleansing; needle stick and blood harvesting; compression after needle removal; and rest (up to 5 minutes after the end of the procedure).	—

Measure

Time frame

Pain responses measured by: 1. Premature Infant Pain Profile Scores 2. Changes in heart rate 3. Changes in oxygen saturation 4. Changes in behavioural state 5. Percentage of time displaying facial actions 6. Heart rate variability 7. Recovery time Primary outcome measures were taken at baseline (30 seconds before venipuncture); during skin cleansing; needle stick and blood harvesting; compression after needle removal; and rest (up to 5 minutes after the end of the procedure).

—

Secondary

Measure	Time frame
Mothers' perception of doing Kangaroo Care during venipuncture was obtained between one and six days after the venipuncture occurred.	—

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026